Evidence · Systematic review or meta-analysis
The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.
- Communicating with families
- Ethics
- Families and professional practice
- Medical
- Nursing
This paper is from 2015, more than five years ago. Newer evidence may have been published since.
Summary
This systematic review uses framework synthesis of 49 empirical studies to examine the ethics of obtaining informed consent for clinical trials involving preterm or sick neonates. It covers parent and clinician attitudes, the validity of consent in the neonatal research context, and alternative consent methods. It finds a strong view that parents should give or decline consent, yet no existing consent process is satisfactory. It highlights that emergency 'assent' followed by later full consent remains unevaluated for acceptability, handling of adverse outcomes and potential bias.
Summary written for NICUlearn. Always read the original.
- Licence:
- Open (Creative Commons)
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